Hannah Clarke

The detection rate ranged from 44% to 58% on day 0 and 58% to 80% on day 1.

“What we hope overall is that this is a biological study that might inform therapeutic development for this disease,” says David A. Braun, MD, PhD.

"The preliminary results of that study, which is a phase 1/2 dose escalation and dose expansion trial, were presented by Professor Ben Tran last year at the ENA meeting1 and showed a very favorable toxicity profile compared to erdafitinib," says Gopa Iyer, MD.

The safety review committee recommended that the phase 2 portion proceed with the 8 GBq dose.

The average life expectancy was 80.3 years among men with a total motile sperm count over 120 million, compared with 77.6 years among men with a total motile sperm count ranging from >0 to 5 million.

The ARID II trial is assessing the safety and effectiveness of the device in men who are scheduled to undergo robotic-assisted radical prostatectomy.

The median OS was 34 months with 177Lu-PSMA-617 plus enzalutamide compared with 26 months with enzalutamide alone.

The FDA is requiring a warning about increased blood pressure and is recommending that the black box warning related to the increased risk of adverse cardiovascular events be removed.

A recap of the FDA submissions and regulatory decisions in urology from February 2025.

Overall, 84.2% of patients achieved a 50% or greater reduction in urgent leaks.

The updates emphasize a risk-stratified approach to the management of microhematuria.

Data from the VAPOR 2 trial are intended to support a submission to the FDA for 510(k) clearance of the device.

The PDUFA date is August 27, 2025.

YOLT-203 was granted an Orphan Drug Designation and a Rare Pediatric Disease Designation in September 2024.

Myriad is planning to launch its first AI-driven prostate cancer clinical test later this year.

The trial plans to enroll up to 80 adult patients with mCRPC who have progressed on prior systemic therapies.

The pCR rate was 33% with APL-1202 plus tislelizumab compared with 26% with tislelizumab alone.

The results encompassed the first 100 patients enrolled in the registry.

The designation is supported by preliminary data from the ongoing phase 1/2a SECuRE trial.

According to ImmunityBio, shipments of rBCG are set to begin immediately via the EAP.

The conditional approval of belzutifan is valid for 1 year, with the opportunity for yearly renewal pending forthcoming data.

However, the triplet regimen did not lead to an improvement in overall survival.

Anktiva is also currently under review for the CIS indication in the EU.

“These data reinforce enfortumab vedotin and pembrolizumab as the new standard of care in frontline urothelial cancer," says Thomas Powles, MD, PhD.

The median duration of response was 47.8 months among patients who achieved an initial complete response.

Illuccix has been previously approved in the US, Australia, Canada, and Europe.

Overall, 85% of respondents indicated they experienced frequent bladder leaks.

The software generates heatmaps to help identify prostatic tumors that may have been missed on initial reads.

At 24 months, 79% of patients experienced a response to therapy, and 56% achieved at least a 75% reduction in UUI episodes.

At a median follow-up of 40.2 months post-surgery, no patients had experienced a disease recurrence.